Recall Z-0500-2024— Luminex Corporation

Name: FDA recall Z-0500-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-07

Class II · Ongoing

Class II FDA medical device recall by Luminex Corporation, initiated 2023-11-07. It names one FDA 510(k) clearance: K122514. Product: Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.. Reason: Potentially defective utility trays in the reagent kits..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-11-07
Firm location: Northbrook, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TESTNanosphere, Inc.·cleared 2012-09-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.

Reason for recall

Potentially defective utility trays in the reagent kits.

Data sourced from openFDA. This site is unofficial and independent of the FDA.